Oesophagus CancerNCT04151524
Classification of Adenocarcinoma of the Esophagogastric Junction
An observational study of Oesophagus Cancer and Barrett Esophagus, run by St. James's Hospital, Ireland at 1 site in Ireland.
Trial summary
The Siewert classification of oesophageal cancer is the standard approach in anatomically subdividing cancer of the lower oesohagus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oesophagus Cancer, Barrett Esophagus, Siewert Type I Adenocarcinoma of Esophagogastric Junction
- How many people
- 1,658 participants
- Where
- 1 siteIreland
- Study dates
- 23 Oct 2019to 1 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Observational study
Who may be able to join
- All patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biologic Classification of Adenocarinoma of the Esophagus and Esophagogastric Junction (AEG) Using a Novel Data-driven System: Should it Replace or Compliment the Siewert Classification?
The Siewert classification of oesophageal cancer is the standard approach in anatomically subdividing cancer of the lower oesohagus.
Read the detailed description
Retrospective review of tumour biology, pathological staging and outcomes in the participants based on Siewert classification. The investigators to scrutinise this scoring system to evaluate if it is indeed appropriate.
- Conditions
- Oesophagus Cancer, Barrett Esophagus, Siewert Type I Adenocarcinoma of Esophagogastric Junction, Siewert Type II Adenocarcinoma of Esophagogastric Junction, Siewert Type III Adenocarcinoma of Esophagogastric Junction
- Medical subject headings
- Esophageal Neoplasms, Barrett Esophagus
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start23 Oct 2019
- Primary completion25 Dec 2019 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophagus CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,658 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Edward Donlon, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151524
- Sponsor's protocol ID
- SJH00002
- Status last verified
- Nov 2019
- First submitted
- 23 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Classification of Adenocarinoma of the Esophagus and Esophagogastric Junction (AEG) Using a Novel Data-driven System: Should it Replace or Compliment the Siewert Classification?
- ClinicalTrials.gov ID
- NCT04151524
- Acronym / sponsor ID
- SJH00002
- Conditions
- Oesophagus Cancer, Barrett Esophagus, Siewert Type I Adenocarcinoma of Esophagogastric Junction, Siewert Type II Adenocarcinoma of Esophagogastric Junction, Siewert Type III Adenocarcinoma of Esophagogastric Junction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,658 participants (actual)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 25 Dec 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Siewert classification of oesophageal cancer is the standard approach in anatomically subdividing cancer of the lower oesohagus.
Detailed description
Retrospective review of tumour biology, pathological staging and outcomes in the participants based on Siewert classification. The investigators to scrutinise this scoring system to evaluate if it is indeed appropriate.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Observational study
Key inclusion criteria (1 listed)
- All patients
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oesophagus Cancer and Barrett Esophagus, run by St. James's Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.